Roche Phase III study misses COVID-19 endpoint
In the Phase III REMDACTA trial, the Swiss pharma major combined its cytokine storm blocker tocolizumab with Gilead Science’s viral transcription blocker remdesivir to improve time to hospital discharge for patients with severe COVID-19 pneumonia. Compared to remdesivir monotherapy there was no significant improvement of the combination therapy in the time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia. As remdesivir has been shown only to be effective in early disease stages this means that tocolizumab shows no clinically beneficial effect on the servere host response observed in this patient group.
Roche, however announced, it will continue to evaluate data from the REMDACTA, COVACTA and EMPACTA studies as well as other studies of tocilizumab in COVID-19 pneumonia. The EMPACTA study met its primary endpoint, while COVACTA did not meet its primary endpoint. Sarilizumab, another blocker of the IL-6 pathway showed the same efficicacy pattern in a study waiting for peer review.
REMDACTA did not meet key secondary endpoints, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. According to Roche, the full results of the trial will be submitted for publication in a peer-reviewed journal later this year.